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临床试验/NCT02114476
NCT02114476Unknown不适用

Effect of Implantable Progestin-only Contraception on the Incidence of Type 2 Diabetes and Metabolic Syndrome in Thai Women With History of Gestational Diabetes

Mahidol University2 个研究点 分布在 1 个国家目标入组 260 人开始时间: 2014年3月最近更新:
适应症

试验速览

阶段
不适用
入组人数
260
试验地点
2
主要终点
Diabetes mellitus

研究概览

简要总结

The purpose of this study is to determine the effect of implantable contraception on the incidence of diabetes mellitus in women with history of gestational diabetes mellitus comparing with those using nonhormonal contraceptives.

详细描述

Gestational diabetes mellitus (GDM) was defined as abnormal glucose tolerance detected for the first time in pregnancy. GDM is a well-known risk factor for developing overt diabetes later in life, especially type 2 diabetes. About 50-60% of woman with prior GDM will develop type 2 diabetes during their lifetime. Recent studies show that women with previous GDM exhibit a markedly increased prevalence of the metabolic syndrome, even when glucose tolerance is normal. For both maternal and future offspring, women with prior GDM need safe, efficient, and acceptable choices for contraceptive methods that do not enhance their already substantial risk to develop either overt diabetes or metabolic syndrome and associated sequelae. The intrauterine device (IUD) is a very effective and reversible contraceptive method without metabolic disturbances and therefore is an ideal contraceptive for women with prior GDM. Progestins do not increase globulin production; thus, they do not increase coagulation factors or blood pressure. A nonrandomized open-label prospective trial of healthy obese, reproductive-age women in California were studied about the metabolic effects of progestin-only long-acting reversible contraception levonorgestrel-releasing intrauterine system (LNG-IUS) and etonogestrel implant (ENG-I)] comparing with nonhormonal contraception (NHC). The changes in fasting glucose and insulin sensitivity were seen among obese at 3 months.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Health Services Research
盲法
None

入排标准

年龄范围
18 Years 至 50 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Postpartum women with diagnosis of gestational diabetes mellitus
  • Want to use implant contraception or nonhormonal contraceptions such as IUD or tubal sterilization

排除标准

  • Age less than 18 years old
  • Diagnosis of diabetes mellitus at post partum period
  • Cardiovascular disease, Liver disease, autoimmune disease
  • The women that reject to continue in the study.

结局指标

主要结局

Diabetes mellitus

时间窗: 5 years

Incidence of type-2 DM in women with history of gestational diabetes using implantable contraception.

次要结局

  • metabolic syndrome(5 years)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Manee Rattanachaiyanont

Department of Obstetrics and Gynecology, Faculty of Medicine Siriraj Hospital

Mahidol University

研究点 (2)

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